Lupus NephritisPhase 2NCT02949349
Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
A Phase 2 study testing Mycophenolate mofetil, Azathioprine and Prednisolone in people with Lupus Nephritis, run by Genovate Biotechnology Co., Ltd.,.
Trial summary
This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the maintenance therapy of lupus nephritis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Mycophenolate mofetil, Azathioprine and Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to 25 Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of lupus nephritis.
- Currently receiving maintenance therapy with Azathioprine, Mycophenolate Mofetil, Mycophenolate Sodium, or Cyclosporine for lupus nephritis for at least 3 months prior to randomization.
- Stable use of low dose (≤10mg/day) oral prednisolone for lupus nephritis for at least 3 months prior to randomization.
Who cannot join
- Untreated, not in need of immunosuppressive treatment (in addition to corticosteroids), currently receiving induction therapy, or not responding to Azathioprine, Mycophenolate Mofetil or Mycophenolate Sodium as induction or maintenance therapy for lupus nephritis.
- Currently receiving or anticipated to receive cyclophosphamide or IV pulse of corticosteroids.
- Currently receiving continuous dialysis starting more than 2 weeks before randomization, and/or with an anticipated duration of more than 8 weeks.
- Previous kidney transplant or planned transplant.
- Presence of life threatening complications such as cerebral lupus or severe infection.
- Presence of liver dysfunction.
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- Presence of COPD or asthma requiring oral steroids.
- Presence of bone marrow insufficiency or pure red cell aplasia unrelated to active systemic lupus erythematosus.
- Presence of persistent hematuria or pyuria for causes other than lupus nephritis.
About this study
This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the maintenance therapy of lupus nephritis.
Read the detailed description
This study is designed to compare the two different doses of Mycocep Capsules (1.0g/day \& 1.5g/day) and Imuran Azathioprine Tablets (2mg/kg/day), all in combination with low-dose prednisolone (≤10mg/day) as maintenance treatment for lupus nephritis.
- Conditions
- Lupus Nephritis
- Being tested
- Mycophenolate mofetil, Azathioprine, Prednisolone
- Keywords
- Systemic Lupus Erythematosus, Lupus Nephritis, Mycophenolate Mofetil, Azathioprine, Maintenance Therapy, Prednisolone, Serum albumin, Serum creatinine, Spot urine protein/creatinine ratio
- Medical subject headings
- Lupus Nephritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Mycocep Capsules
Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks.
AzathioprineDrug
Also called Imuran Azathioprine Tablets
Provided as 50mg/tablet, 1mg/kg, orally twice a day, for 24 weeks.
PrednisoloneDrug
Daily dose not more than 10mg, orally, for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| MMF 500mg | Experimental | Mycophenolate mofetil 500mg, PO BID Receives: Drug: Mycophenolate mofetil; Drug: Prednisolone |
| MMF 750mg | Experimental | Mycophenolate mofetil 750mg, PO BID Receives: Drug: Mycophenolate mofetil; Drug: Prednisolone |
| AZA | Active comparator | Azathioprine 1mg/kg, PO BID Receives: Drug: Azathioprine; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum albumin
Measured: 24 weeks treatment
Change in serum creatinine
Measured: 24 weeks treatment
Change in spot urine protein/creatinine ratio
Measured: 24 weeks treatment
Secondary outcomes (8)
Change in serum albumin
Measured: 12 weeks treatment
Change in serum creatinine
Measured: 12 weeks treatment
Change in spot urine protein/creatinine ratio
Measured: 12 weeks treatment
Change in cholesterol
Measured: 24 weeks treatment
Change in triglyceride
Measured: 24 weeks treatment
Change in complete blood count/differential count (CBC/DC)
Measured: 24 weeks treatment
Change in number of subjects with doubling of serum creatinine
Measured: 24 weeks treatment
Change in the average daily dose of oral prednisolone
Measured: 24 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startJul 2015
- Primary completion30 Dec 2016
- Study completion25 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genovate Biotechnology Co., Ltd.,
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ming-Han Chen, M.D., Ph.D., Principal investigator, Taipei Veterans General Hospital, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949349
- Sponsor's protocol ID
- GBL15-001
- Status last verified
- Mar 2017
- First submitted
- 25 Oct 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
- ClinicalTrials.gov ID
- NCT02949349
- Acronym / sponsor ID
- GBL15-001
- Conditions
- Lupus Nephritis
- Keywords
- Systemic Lupus Erythematosus, Lupus Nephritis, Mycophenolate Mofetil, Azathioprine, Maintenance Therapy, Prednisolone, Serum albumin, Serum creatinine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Genovate Biotechnology Co., Ltd.,Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 25 Jan 2017 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the maintenance therapy of lupus nephritis.
Detailed description
This study is designed to compare the two different doses of Mycocep Capsules (1.0g/day \& 1.5g/day) and Imuran Azathioprine Tablets (2mg/kg/day), all in combination with low-dose prednisolone (≤10mg/day) as maintenance treatment for lupus nephritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MMF 500mg | Experimental | Drug: Mycophenolate mofetil, Drug: PrednisoloneMycophenolate mofetil 500mg, PO BID |
| MMF 750mg | Experimental | Drug: Mycophenolate mofetil, Drug: PrednisoloneMycophenolate mofetil 750mg, PO BID |
| AZA | Active comparator | Drug: Azathioprine, Drug: PrednisoloneAzathioprine 1mg/kg, PO BID |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of lupus nephritis.
- Currently receiving maintenance therapy with Azathioprine, Mycophenolate Mofetil, Mycophenolate Sodium, or Cyclosporine for lupus nephritis for at least 3 months prior to randomization.
- Stable use of low dose (≤10mg/day) oral prednisolone for lupus nephritis for at least 3 months prior to randomization.
Key exclusion criteria (9 listed)
- Untreated, not in need of immunosuppressive treatment (in addition to corticosteroids), currently receiving induction therapy, or not responding to Azathioprine, Mycophenolate Mofetil or Mycophenolate Sodium as induction or maintenance therapy for lupus nephritis.
- Currently receiving or anticipated to receive cyclophosphamide or IV pulse of corticosteroids.
- Currently receiving continuous dialysis starting more than 2 weeks before randomization, and/or with an anticipated duration of more than 8 weeks.
- Previous kidney transplant or planned transplant.
- Presence of life threatening complications such as cerebral lupus or severe infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycophenolate mofetilAlso: Mycocep CapsulesProvided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks. | Drug | MMF 500mg, MMF 750mg |
| AzathioprineAlso: Imuran Azathioprine TabletsProvided as 50mg/tablet, 1mg/kg, orally twice a day, for 24 weeks. | Drug | AZA |
| PrednisoloneDaily dose not more than 10mg, orally, for 24 weeks. | Drug | AZA, MMF 500mg, MMF 750mg |
Primary outcome
Change in serum albumin
Time frame: 24 weeks treatment
Change in serum creatinine
Time frame: 24 weeks treatment
Change in spot urine protein/creatinine ratio
Time frame: 24 weeks treatment
8 secondary outcomes
Change in serum albumin
Time frame: 12 weeks treatment
Change in serum creatinine
Time frame: 12 weeks treatment
Change in spot urine protein/creatinine ratio
Time frame: 12 weeks treatment
Change in cholesterol
Time frame: 24 weeks treatment
Change in triglyceride
Time frame: 24 weeks treatment
Change in complete blood count/differential count (CBC/DC)
Time frame: 24 weeks treatment
Change in number of subjects with doubling of serum creatinine
Time frame: 24 weeks treatment
Change in the average daily dose of oral prednisolone
Time frame: 24 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Han Chen, M.D., Ph.D. principal investigator
Taipei Veterans General Hospital, Taiwan, R.O.C.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mycophenolate mofetil, Azathioprine and Prednisolone in people with Lupus Nephritis, run by Genovate Biotechnology Co., Ltd.,.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum albumin (time frame: 24 weeks treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.